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Phase 2 N=16 Treatment

Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia

B-Cell Prolymphocytic Leukemia · Hypodiploidy · Loss of Chromosome 17p · Plasma Cell Leukemia · Progression of Multiple Myeloma or Plasma Cell Leukemia

Enrolled (actual)
16
Serious AEs
6.3%
Results posted
May 2019
Primary outcome: Primary: Event-Free Survival (EFS) — 9 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Allogeneic Bone Marrow Transplantation (Procedure); Allogeneic Hematopoietic Stem Cell Transplantation (Procedure); Autologous Hematopoietic Stem Cell Transplantation (Procedure); Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation (Procedure); Carmustine (Drug); Cyclophosphamide (Drug); Cytarabine (Drug); Etoposide (Drug); Fludarabine Phosphate (Drug); Laboratory Biomarker Analysis (Other); Melphalan (Drug); Mycophenolate Mofetil (Drug); Peripheral Blood Stem Cell Transplantation (Procedure); Tacrolimus (Drug); Total-Body Irradiation (Radiation)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Fred Hutchinson Cancer Center
Primary completion
Jun 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Event-Free Survival (EFS)
9
SECONDARY
Number of Patients With Relapsed/Progressive Disease
6
SECONDARY
Overall Survival
10
SECONDARY
Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
8; 1
SECONDARY
Non-relapse Mortality (NRM)
0; 1
SECONDARY
Number of Patients Who Engrafted
13
SECONDARY
Number of Patients Who Had Infections
16

Summary

This phase II trial studies autologous peripheral blood stem cell transplant followed by donor bone marrow transplant in treating patients with high-risk Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, or chronic lymphocytic leukemia. Autologous stem cell transplantation uses the patient's stem cells and does not cause graft versus host disease (GVHD) and has a very low risk of death, while minimizing the number of cancer cells. Peripheral blood stem cell (PBSC) transplant uses stem cells from the patient or a donor and may be able to replace immune cells that were destroyed by chemotherapy. These donated stem cells may help destroy cancer cells. Bone marrow transplant known as a nonmyeloablative transplant uses stem cells from a haploidentical family donor. Autologous peripheral blood stem cell transplant followed by donor bone marrow transplant may work better in treating patients with high-risk Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, or chronic lymphocytic leukemia.

Eligibility Criteria

Inclusion Criteria

  • Must have the capacity to give informed consent
  • Detectable tumor prior to mobilization regimen
  • Patients with stored autologous stem cells will be allowed
  • Stem cells from an identical donor could be used for autologous hematopoietic cell transplant (HCT)
  • Marrow is the preferred source of stem cells from the HLA-haploidentical donor, however, peripheral blood mononuclear cells (PBMC) could be used as stem cell source, after clearance with the Fred Hutchinson Cancer Research Center (FHCRC) principal investigator, in the case of difficulties or contraindications to bone marrow harvest from the donor
  • Cross-over to other tandem autologous-allogeneic research protocol (#1409 or other appropriate protocol) will be allowed if a suitable HLA-matched related or unrelated donor is identified before receiving the allogeneic transplantation and if the patient meets the eligibility criteria of the subsequent study
  • Cross-over from other tandem autologous-allogeneic research protocol (#1409 or other appropriate protocol) will be allowed if the patient loses the suitable HLA-matched related or unrelated donor but has an available HLA-haploidentical donor before receiving the allogeneic transplantation and if the patient meets the eligibility criteria of the subsequent study
  • Lymphoma: patients with
  • Diagnosis of non-Hodgkin lymphoma (NHL) or Hodgkin's lymphoma (HL), of any histological grade
  • Refractory or relapsed disease after standard chemotherapy
  • High risk of early relapse following autograft alone
  • Waldenstrom's macroglobulinemia: must have failed 2 courses of therapy
  • CLL:
  • Patients with either a:
  • Diagnosis of T-cell CLL or T-cell prolymphocytic leukemia (PLL) who have failed initial chemotherapy, patients with T cell CLL or PLL or
  • Diagnosis of B-cell CLL, B-cell small lymphocytic lymphoma, or B-cell CLL that progressed to PLL who either:
  • Failed to meet National Cancer Institute (NCI) Working Group criteria for complete or partial response after therapy with a regimen containing fludarabine (or another nucleoside analog, e.g. 2-chlorodeoxyadenosine [CDA], pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing fludarabine (or another nucleoside analog)
  • Failed any aggressive chemotherapy regimen, such as fludarabine, cyclophosphamide and rituximab (FCR), at any time point
  • Have "17p deletion" cytogenetic abnormality and relapsed at any time point after initial chemotherapy
  • Harvesting criteria for autologous HCT:
  • Previously collected PBMC may be used
  • Circulating CLL cells 5.5 mg/ml,
  • Cytogenetic hypodiploidy
  • Plasmablastic morphology (>= 2%)
  • Recurrent or non-responsive (less than partial remission [PR]) MM after at least two different lines of conventional chemotherapy
  • Progressive MM after a previous autograft (provided stored autologous cluster of differentiation [CD]34 cells are available)
  • Plasma cell leukemia: after induction chemotherapy
  • DONOR: Related donors who are genotypically identical for one HLA haplotype and who may be mismatched at the HLA-A, -B, -C or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or -C allele mismatches
  • DONOR: Marrow is the preferred source of stem cells from the HLA-haploidentical donor, however PBMC could be used as stem cell source, after clearance with the FHCRC principal investigator, in the case of difficulties or contraindications to bone marrow harvest from the donor
  • DONOR: In the case that PBMC will be used as stem cell source, ability of donors = 12 years of age

Exclusion Criteria

  • Life expectancy severely limited by disease other than malignancy
  • Seropositive for the human immunodeficiency virus
  • Female patients who are pregnant or breastfeeding
  • Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
  • Central nervous system (CNS) involvement with disease refractory to intratheca
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01008462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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